NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy - Full Text View

Purpose

To conduct a collaborative program of research on asthma and pregnancy consisting of two studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate relationships between asthma severity and treatment programs and perinatal outcome, and the Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group of participating obstetric centers supported by the National Institute of Child Health and Human Development. Studies were co-funded by the NHLBI.

Condition	Intervention	Phase
Asthma Lung Diseases	Drug: theophylline Drug: beclomethasone	Phase III

MedlinePlus related topics:

Asthma

Drug Information available for:

Beclomethasone dipropionate Beclomethasone Theophylline Theophylline sodium glycinate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:	April 1994
Estimated Study Completion Date:	October 2000

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Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Asthmatic pregnant women.

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

Wright LL, McNellis D. National Institute of Child Health and Human Development (NICHD)-sponsored Perinatal Research Networks. Semin Perinatol. 1995 Apr;19(2):112-23. Review. No abstract available.

Dombrowski MP, Schatz M, Wise R, Momirova V, Landon M, Mabie W, Newman RB, McNellis D, Hauth JC, Lindheimer M, Caritis SN, Leveno KJ, Meis P, Miodovnik M, Wapner RJ, Paul RH, Varner MW, O'Sullivan MJ, Thurnau GR, Conway DL; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network and the National Heart, Lung, and Blood Institute. Asthma during pregnancy. Obstet Gynecol. 2004 Jan;103(1):5-12.

Dombrowski MP, Schatz M, Wise R, Thom EA, Landon M, Mabie W, Newman RB, McNellis D, Hauth JC, Lindheimer M, Caritis SN, Leveno KJ, Meis P, Miodovnik M, Wapner RJ, Varner MW, O'Sullivan MJ, Conway DL; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network; National Heart, Lung, and Blood Institute. Randomized trial of inhaled beclomethasone dipropionate versus theophylline for moderate asthma during pregnancy. Am J Obstet Gynecol. 2004 Mar;190(3):737-44.

Study ID Numbers:	216
First Received:	October 27, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000578
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Beclomethasone

Asthma

Theophylline

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Vasodilator Agents

Molecular Mechanisms of Pharmacological Action

Bronchial Diseases

Immune System Diseases

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents

Enzyme Inhibitors

Cardiovascular Agents

Glucocorticoids

Hormones

Pharmacologic Actions

Phosphodiesterase Inhibitors

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on December 03, 2008

Sponsors and Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000578